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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Chemoprevention Study of Acetylsalicylic Acid (Aspirin) in Patients at Increased Risk for the Development or Recurrence of Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Biomarker/Laboratory analysis, Prevention Active Under 75 NCI NU-NWU04-2-03 NWU04-2-03, NCT00468910

Trial Description

Purpose:

Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.

This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer.

Eligibility:

Eligibility criteria include the following:

• Younger than 75 years old
• Diagnosis of colon adenoma or colorectal cancer within the past 6 years or currently has a colon adenoma or polyps
• No cancer within the past 6 months
• Planning to undergo colonoscopy
• At least 6 months since treatment for cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive aspirin by mouth once a day for up to 3 months.

Patients in group two will receive a placebo by mouth once a day for up to 3 months.

Patients will undergo sigmoidoscopy, biopsies, and blood sample collection at the beginning of the study and after finishing treatment for laboratory studies.

After finishing treatment, patients will be evaluated at 3 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Raymond Bergan, MD, Principal investigator		Ph: 312-908-5284 Email: r-bergan@northwestern.edu

U.S.A.
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu
	University of Chicago Cancer Research Center
		David Rubin, MD	Ph:  773-702-4708
			Email: drubin@uchicago.edu
	Evanston
	Evanston Northwestern Healthcare - Evanston Hospital
		Clinical Trials Office - Evanston Northwestern Healthcare - Evanston Hospital	Ph:  847-570-1381

Registry Information
Official Title		Spectral Markers In Aspirin Chemoprevention of Colonic Neoplasia
Trial Start Date		2007-03-24
Trial Completion Date		2010-02-28 (estimated)
Registered in ClinicalTrials.gov		NCT00468910
Date Submitted to PDQ		2007-03-23
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA60553, CN35159